OUR COMMITMENT
Safety & Ethics
Patient safety and ethical research practices are fundamental to everything we do.
Patient Safety First
The safety of patients and research participants is our highest priority. All our research is conducted under strict safety protocols, with multiple layers of oversight and review.
Our iPS-derived exosomes are produced in GMP-compliant facilities with rigorous quality control at every step, from donor screening through final product release.
Safety Measures
Regulatory Compliance
Our products meet the strict regulatory standards of multiple international jurisdictions.
Japan
Compliant with PMDA regulations for regenerative medicine products and cell-based therapies.
United States
Aligned with FDA guidance for human cells, tissues, and cellular and tissue-based products.
Europe
Manufactured under EMA guidelines for advanced therapy medicinal products (ATMPs).
Ethical Framework
Our research is guided by internationally recognized ethical principles and conducted under the oversight of independent ethics committees.
Informed Consent
All donors and research participants provide informed consent after receiving comprehensive information about procedures and potential risks.
Privacy Protection
Donor information is protected in accordance with applicable privacy laws and international data protection standards.
Ethical Sourcing
iPS cells are derived from adult cells, avoiding ethical concerns associated with embryonic stem cell sources.
Research Integrity
We are committed to the highest standards of scientific integrity and transparent reporting of all research findings.
Pre-Registration
Clinical studies are registered in public databases before enrollment begins, with pre-specified endpoints.
Publication Policy
All results are submitted for publication regardless of outcome, including negative and inconclusive findings.
Conflict of Interest
Financial and non-financial interests are disclosed in all publications and presentations.
Quality Management
Comprehensive quality systems ensure consistency and safety across all operations.
GMP Manufacturing
- •Cleanroom facilities with environmental monitoring
- •Validated manufacturing processes
- •Trained personnel with documented qualifications
- •Equipment calibration and maintenance
- •Document control and record keeping
- •Deviation and CAPA management
Quality Control Testing
- •Identity and purity testing
- •Sterility and mycoplasma testing
- •Endotoxin testing
- •Potency assays
- •Stability studies
- •Certificate of Analysis for each batch
Important Notice
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Questions About Safety?
Contact our team for more information about our safety protocols and quality systems.